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EC number: 941-787-9 | CAS number: 98222-50-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
The following classification criteria apply:
EU DSD & CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
Eye irritation:
No category. Not requiring classification to UN GHS or EU CLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 October 2015 - 26 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Variation between the three identically treated negative control tissues exceeded the ≤ 18% standard deviation limit as given in the study protocol. The standard deviation for the negative control group in this study was 20%. However as there was a high confidence in the results, ie there were no borderline results in the negative control, positive control or test item treated groups a repeat of the study was considered unnecessary.
- Deviations:
- yes
- Remarks:
- This deviation was considered not to affect the purpose or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Variation between the three identically treated negative control tissues exceeded the ≤ 18% standard deviation limit as given in the study protocol. The standard deviation for the negative control group in this study was 20%. However as there was a high confidence in the results, ie there were no borderline results in the negative control, positive control or test item treated groups a repeat of the study was considered unnecessary.
- Deviations:
- yes
- Remarks:
- This deviation was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch: L002
Purity: 95.4%
Physical state / Appearance: Pale yellow liquid
Expiry date: 15 August 2016
Storage Conditions: Room temperature in the dark - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The main basal, supra basal, spinous and granular layers and a functional stratum corneum.
- Source strain:
- not specified
- Justification for test system used:
- Reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation when the endpoint is measured by MTT reduction and for being used as a replacement for the Draize Skin Irritation Test for the purpose of distinguishing between Irritating and Non-Irritating test items.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation (if applicable): 37 °C
DYE BINDING METHOD
- Dye used in the dye-binding assay:MTT
- Spectrophotometer: microplate reader
- Wavelength: 562 nm
- Filter:without
- Filter bandwidth: na
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if relative mean tissue viability is ≤50%
- The test substance is considered to be non-irritant to skin if relative mean tissue viability is >50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 µL
- Concentration (if solution): 26.3 µL/cm2
NEGATIVE CONTROL
- Amount(s) applied: 10 µL of DPBS
POSITIVE CONTROL
- Amount(s): 10 µL of SDS 5% w/v: positive control - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main
- Value:
- 82.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not valid
- Remarks:
- There were no borderline results in the negative control, positive control or test item treated groups a repeat of the study was considered unnecessary.
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Mean OD562 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item (Table 1).
- Interpretation of results:
- GHS criteria not met
- Remarks:
- UN GHS Not classified for Irritation (category 3 can not be determined).
- Conclusions:
- The test item was classified as non-irritant.
The following classification criteria apply:
EU DSD & CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
Reference
Table 1: Mean OD562 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD562of tissues |
Mean OD562of triplicate tissues |
±SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
0.871 |
0.702 |
0.146 |
124.1 |
100* |
20.8 |
0.619 |
88.2 |
|||||
0.617 |
87.9 |
|||||
Positive Control Item |
0.042 |
0.084 |
0.041 |
6.0 |
12.0 |
5.9 |
0.124 |
17.7 |
|||||
0.085 |
12.1 |
|||||
Test Item |
0.642 |
0.580 |
0.056 |
91.5 |
82.6 |
8.0 |
0.564 |
80.3 |
|||||
0.534 |
76.1 |
OD=Optical Density
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 November 2015 - 04 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch: L002
Purity: 95.4%
Physical state/Appearance: pale yellow liquid
Expiry Date: 15 August 2016
Storage Conditions: room temperature in the dark - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: local abattoir
- Age of animals: 12 to 60 months old
- Storage: refrigerated on arrival and used within 24 hours of receipt - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL of the test item or control items
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: Only corneas free of damage were used.
QUALITY CHECK OF THE ISOLATED CORNEAS: macroscopically examined before and after dissection
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: 0.9% w/v sodium chloride solution
POSITIVE CONTROL USED: Ethanol
APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL of the test item or control items for 10 minutes at 32 ± 1 ºC
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: yes, 120 minutes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 4
- POST-EXPOSURE INCUBATION: 120 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Each cornea was visually observed
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microplate reader (OD492)
- Histopathology: possible conduct of histopathology
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS CLASSIFICATION
≤ 3 No category. Not requiring classification to UN GHS or EU CLP
> 3; ≤55 No prediction of eye irritation can be made
> 55 Category 1. UN GHS or EU CLP Causes serious eye damage - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main
- Value:
- 1.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Corneal Opacity and Permeability Measurement: Table 1
Corneal Epithelium Condition: Table 2 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No category. Not requiring classification to UN GHS or EU CLP.
Reference
Table 1 Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
CorneaNumber |
|
Opacity |
Permeability(OD) |
InVitroIrritancyScore |
||||
Pre-Treatment |
Post-Treatment |
PostIncubation |
Post-Incubation -Pre-Treatment |
CorrectedValue |
|
CorrectedValue |
|||
Negative Control |
19 |
4 |
5 |
5 |
1 |
|
0.006 |
|
|
22 |
4 |
4 |
6 |
2 |
|
0.004 |
|
|
|
23 |
4 |
4 |
6 |
2 |
|
0.001 |
|
|
|
|
|
|
|
1.7* |
|
0.004¨ |
|
1.7 |
|
Positive Control |
5 |
3 |
35 |
33 |
30 |
28.3 |
0.446 |
0.442 |
|
18 |
3 |
35 |
34 |
31 |
29.3 |
1.308 |
1.304 |
|
|
24 |
4 |
31 |
29 |
25 |
23.3 |
0.880 |
0.876 |
|
|
|
|
|
|
|
27.0· |
|
0.874· |
40.1 |
|
Test Item |
26 |
4 |
4 |
4 |
0 |
0.0 |
0.065 |
0.061 |
|
27 |
3 |
4 |
4 |
1 |
0.0 |
0.006 |
0.002 |
|
|
28 |
4 |
3 |
9 |
5 |
3.3 |
0.008 |
0.004 |
|
|
|
|
|
|
|
1.1· |
|
0.023· |
1.5 |
OD=Opticaldensity *=Meanofthepost-incubation-pre-treatmentvalues ¨=Meanpermeability ·=Meancorrectedvalue
Table 2 Corneal Epithelium Condition Post Treatment and Post Incubation
Treatment |
CorneaNumber |
Observation |
|
PostTreatment |
PostIncubation |
||
Negative Control |
19 |
clear |
clear |
22 |
clear |
clear |
|
23 |
clear |
clear |
|
Positive Control |
5 |
cloudy |
cloudy |
18 |
cloudy |
cloudy |
|
24 |
cloudy |
cloudy |
|
Test Item |
26 |
clear |
clear |
27 |
clear |
clear |
|
28 |
clear |
clear |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
A Skin Irritation study (Envigo Research Limiteds, 2016, study code 41501808) was conducted to determine the skin irritation potential of Dailube-IS. The study was performed according to OECD test guideline 439, EU Method B46, and in compliance with GLP.
The effects of 15-minute dermal exposure to Dailube-IS were investigated in EPISKINTMreconstructed human epidermis model. Triplicate tissues were treated with 10 µL of Dailube-IS. At the end of the exposure period, each tissue was removed from the well using forceps and rinsed. The rinsed tissues were incubated for 42 hours.
The relative mean viability of the test item treated tissues was 82.6% after the 15‑Minute exposure period and 42‑hours post‑exposure incubation period.
As the relative mean viability of the test item treated tissues was greater than 50%, Dailube-IS is not classified as irritant to skin.
An Eye Irritation study (Envigo Research Limited, 2016, 41501809) was conducted to assess the effect of the instillation of Dailube-IS into the eyes from adult cattles. The study was performed according to OECD test guideline 437, EU Method B47, and in compliance with GLP.
0.75 mL of undiluted Dailube-IS was applied to three corneas for 10 minutes. At the end of the exposure period the corneas were rinsed and incubated for 120 minutes. The in vitro irritancy score of Dailube-IS was found to be 1.5.
As the in vitro irritancy score was less than 3 Dailube-IS is not classified as irritant to eyes.
Effects on skin irritation/corrosion: non-irritating
Effects on eye irritation: non- irritating
On the basis of the above studies, Dailube-IS does not meet the criteria for classification as a skin or eye irritant.
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